Safety Tolerability and Pharmacokinetic of BI 409306

NCT ID: NCT01343706

Last Updated: 2024-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-01
• Study Completion Date: 2011-08-05

Brief Summary

The primary objective of the current study is to investigate the safety and tolerability of BI 409306 in healthy male genotyped volunteers following oral administration of single rising doses.

The secondary objectives are: (1) to explore dose proportionality of BI 409306 as immediate release solid oral dosage, (2) to explore the relative bioavailability of BI 409306 when administered as immediate release solid oral dosage compared to oral drinking solution and (3) to compare the safety and pharmacokinetic profiles between two different groups of genotyped subjects.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

BI 409306 0.5 mg PiB [EM]

Extensive metaboliser \[EM\] subjects administered one single dose of 0.5 milligram (mg) BI 409306 powder in bottle (PiB) reconstituted for oral solution (0.5 mg /milliliter (mL)) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 mL drinking water) after an overnight fast of at least 10 hours.

Group Type: EXPERIMENTAL

BI 409306

Intervention Type: DRUG

solution for oral administration

BI 409306 2 mg PiB [EM]

EM subjects administered one single dose of 2 mg BI 409306 PiB reconstituted for oral solution (0.5 mg/mL) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 milliliter drinking water) after an overnight fast of at least 10 hours.

Group Type: EXPERIMENTAL

BI 409306

Intervention Type: DRUG

solution for oral administration

BI 409306 5 mg PiB followed by BI 409306 5 mg Tablet [EM]

EM subjects administered one single dose of 5 mg BI 409306 powder in bottle (PiB) reconstituted for oral solution (0.5 mg/ mL) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 mL drinking water) after an overnight fast of at least 10 hours in period 1; followed by a washout period of 5 days; followed by one single dose of 5 mg BI 409306 immediate release tablet administered orally with 240 mL water after an overnight fast of at least 10 hours in period 2.

Group Type: EXPERIMENTAL

BI 409306

Intervention Type: DRUG

Immediate release solid oral dosage (film-coated tablet)

BI 409306

Intervention Type: DRUG

solution for oral administration

BI 409306 10 mg Tablet [EM]

EM subjects administered 2 immediate release tablets of 5 mg BI 409306 as a single dose (total dosage: 10 mg) orally with 240 mL water after an overnight fast of at least 10 hours.

Group Type: EXPERIMENTAL

BI 409306

Intervention Type: DRUG

Immediate release solid oral dosage (film-coated tablet)

BI 409306 25 mg Tablet [EM]

EM subjects administered 5 immediate release tablets of 5 mg BI 409306 as a single dose (total dosage: 25 mg) orally with 240 mL water after an overnight fast of at least 10 hours.

Group Type: EXPERIMENTAL

BI 409306

Intervention Type: DRUG

Immediate release solid oral dosage (film-coated tablet)

BI 409306 50 mg Tablet followed by BI 409306 50mg PiB [EM]

EM subjects administered one single dose of 50 mg BI 409306 immediate release tablet orally with 240 mL water in period 1; followed by a washout period of 5 days; followed by one single dose of 50 mg BI 409306 powder in bottle (PiB) reconstituted for oral solution (0.5 mg/mL) in a volume of 80 mL of the solvent containing aqueous 0.5% tartaric acid solution administered orally with 240 mL water (160 mL containing the respective diluted volume of reconstituted solution and 80 mL drinking water) after an overnight fast of at least 10 hours in period 2.

Group Type: EXPERIMENTAL

BI 409306

Intervention Type: DRUG

Immediate release solid oral dosage (film-coated tablet)

BI 409306

Intervention Type: DRUG

solution for oral administration

BI 409306 100 mg Tablet [EM]

EM subjects administered 2 immediate release tablets of 50 mg BI 409306 as single dose (total dosage: 100 mg) orally with 240 mL water after an overnight fast of at least 10 hours.

Group Type: EXPERIMENTAL

BI 409306

Intervention Type: DRUG

Immediate release solid oral dosage (film-coated tablet)

BI 409306 200 mg Tablet [EM]

EM subjects administered 1 immediate release tablet of 150 mg and 1 immediate release tablet of 50 mg of BI 409306 together as single dose (total dosage: 200 mg) orally with 240 mL water after an overnight fast of at least 10 hours.

Group Type: EXPERIMENTAL

BI 409306

Intervention Type: DRUG

Immediate release solid oral dosage (film-coated tablet)

BI 409306 350 mg Tablet [EM]

EM subjects administered 2 immediate release tablet of 150 mg and 1 immediate release tablet of 50 mg of BI 409306 together as single dose (total dosage: 350 mg) orally with 240 mL water after an overnight fast of at least 10 hours.

Group Type: EXPERIMENTAL

BI 409306

Intervention Type: DRUG

Immediate release solid oral dosage (film-coated tablet)

BI 409306 10 mg Tablet followed by BI 409306 100mg Tablet [PM]

Poor metaboliser \[PM\] subjects administered 2 immediate release tablets of 5 mg BI 409306 as single dose (total dosage: 10 mg) orally with 240 mL water after an overnight fast of at least 10 hours in period 1; followed by washout period of 5 days; followed by 2 immediate release tablets of 50 mg BI 409306 administered as single dose (total dosage: 100 mg) orally with 240 mL water after an overnight fast of at least 10 hours in period 2.

Group Type: EXPERIMENTAL

BI 409306

Intervention Type: DRUG

Immediate release solid oral dosage (film-coated tablet)

Placebo matching to BI 409306 PiB

Subjects administered one single dose of placebo matching to BI 409306 powder in bottle (PiB) after an overnight fast of at least 10 hours.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Solution for oral administration

Placebo matching to BI 409306 film-coated tablet

Subjects administered one single dose of placebo matching to the BI 409306 film-coated tablet (5 milligrams (mg), 50 mg, and 150 mg) orally with 240 mL water after an overnight fast of at least 10 hours.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Immediate release solid oral dosage (film-coated tablet)

Interventions

Placebo

Solution for oral administration

Intervention Type: DRUG

Placebo

Immediate release solid oral dosage (film-coated tablet)

Intervention Type: DRUG

BI 409306

Immediate release solid oral dosage (film-coated tablet)

Intervention Type: DRUG

BI 409306

solution for oral administration

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Healthy males according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), clinical laboratory tests

2. Age > 21 and Age < 50 years

3. Body Mass Index (BMI) > 18.5 and BMI < 29.9 kg/m2

Exclusion Criteria

1. Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance

2. Any evidence of a clinically relevant concomitant disease

3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders

4. Surgery of the gastrointestinal tract (except appendectomy)

5. Diseases of the central nervous system (including but not limited to any kind of seizures, stroke or psychiatric disorders) within the past 6 month

6. History of relevant orthostatic hypotension, fainting spells or blackouts.

7. Chronic or relevant acute infections

8. History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)

9. Use of drugs which might reasonably influence the results of the trial or that prolong the QT/QTc interval based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial

10. Any laboratory value outside the reference range that is of clinical relevance

11. A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms);

12. A history of additional risk factors for Torsades de points (TdP) (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

1289.1.1 Boehringer Ingelheim Investigational Site

Ingelheim, , Germany

Countries

Germany

Other Identifiers

2010-023604-27

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1289.1

Identifier Type: -

Identifier Source: org_study_id